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Completed

NCT Number: NCT01908790

Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter

The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.

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Key information

Conditions

Validation of Oximeter System Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

About this study

The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures arterial blood oxygenation. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.

The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-Oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to critically ill patients.

By non-invasively monitoring venous blood oxygenation, the Mespere Oximeter provides more complete information on patient hemodynamics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Heart failure patients already receiving RHC as part of their usual care
  • Signed written and informed consent

Exclusion criteria

  • Lack of patient consent
  • Subject is pregnant
  • Evidence of abnormal neck anatomy
  • Subject does not have visible left and right jugular veins
  • Subject has occluded internal jugular veins under ultrasound imaging
  • Allergic to adhesive tape
  • Ongoing photodynamic therapy
  • Presence of known anatomical shunt or AV dialysis fistula
  • Known central vein stenosis

Treatment and study plan

Mespere Venous Oximeter

Device

The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.

Avoximeter 4000

Device

The portable Avoximeter 4000 provides rapid, accurate assessment of the patient's true oxygenation status at the bedside. Features: Results in less than 10 seconds; No sample preparation required; Uses whole blood sample; Easy to use.

Primary outcomes

  1. Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter

    Time frame: 0-10 minutes

Sponsors and collaborators

Lead sponsor

Mespere Lifesciences Inc.

Industry

Collaborators

  • University of Michigan

Registry information

Official study title

Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Venous Oxygen Saturation From Blood Samples From the Jugular Vein vs Central Venous Oxygen Saturation vs Mixed Venous Oxygen Saturation, Measured by a CO-Oximeter.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2013
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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